510(k) · Cleared
ClearedAquilion Precision (TSX-304A/4) V10.10 with AiCE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canon Medical Systems Corporation · JAK System, X-Ray, Tomography, Computed
Cleared on Sep 12, 2022 as substantially equivalent to K182901 (Canon Medical Systems Corporation, 2019) after a 161-day review. Its family tree reaches back 5 generations to 2012. 2 later devices descend from it.
- Decided
- Sep 12, 2022
- Review
- 161 days
- Class
- Class II
- Product code
- JAK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K120710 (2012). 2 later devices descend from it, 1 citing it directly.
- Root · 5 generations backK120710 Aquilion PrimeToshibamedical Systems Corporation · 2012 · Recalled
- 4 generations backK130645 Aquilion Prime, V5.00Toshibamedical Systems Corporation · 2013
- 3 generations backK141741 Aquilion Prime, V6.00Toshibamedical Systems Corporation · 2014 · Recalled
- 2 generations backK173468 Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0Toshibamedical Systems Corporation · 2018 · Recalled
- 1 generation backK182901 Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCECanon Medical Systems Corporation · 2019
- This deviceK220986 Aquilion Precision (TSX-304A/4) V10.10 with AiCECanon Medical Systems Corporation · 2022
- Descendant · cites it directly · 1 of its ownK223726 Aquilion Precision (TSX-304A/4) V10.14 with AiCECanon Medical Systems Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK243398 CT Scanner TSX-501R/1 V11.1Canon Medical Systems Corporation · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K120710 | Aquilion Prime | Toshibamedical Systems Corporation | 2012 | 2 |
| −4 | K130645 | Aquilion Prime, V5.00 | Toshibamedical Systems Corporation | 2013 | — |
| −3 | K141741 | Aquilion Prime, V6.00 | Toshibamedical Systems Corporation | 2014 | 2 |
| −2 | K173468 | Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 | Toshibamedical Systems Corporation | 2018 | 1 |
| −1 | K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE | Canon Medical Systems Corporation | 2019 | — |
| 0 (this device) | K220986 | Aquilion Precision (TSX-304A/4) V10.10 with AiCE | Canon Medical Systems Corporation | 2022 | — |
| +1 | K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | Canon Medical Systems Corporation | 2023 | — |
| +2 | K243398 | CT Scanner TSX-501R/1 V11.1 | Canon Medical Systems Corporation | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JAK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JAK device
- #1 K230223 iCAC Devicescore 23.5 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K182901 | Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCESummary page 5…21 CFR System, X-ray, (TSX-304A/1 and /2) Medical Tomography K182901 July 5, 2019 §892.1750 Tomography, V8.8 with AiCE… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K223726 | Aquilion Precision (TSX-304A/4) V10.14 with AiCE | 2023 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K223726 (Canon Medical Systems Corporation, 2023) has gone furthest, with 1 descendant of its own.
How does its category compare?
All JAK devicesJAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · JAK
27in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAK
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAK
17in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAK
219in 2025
MAUDE reports naming product code JAK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 27 | 11 | 76 |
| 2008 | 26 | 42 | 16 | 120 |
| 2009 | 15 | 31 | 29 | 105 |
| 2010 | 7 | 92 | 51 | 119 |
| 2011 | 16 | 155 | 34 | 205 |
| 2012 | 28 | 121 | 23 | 192 |
| 2013 | 17 | 132 | 11 | 414 |
| 2014 | 30 | 200 | 10 | 308 |
| 2015 | 30 | 140 | 28 | 454 |
| 2016 | 25 | 129 | 44 | 365 |
| 2017 | 29 | 96 | 33 | 338 |
| 2018 | 24 | 114 | 10 | 543 |
| 2019 | 28 | 94 | 5 | 233 |
| 2020 | 30 | 112 | 8 | 177 |
| 2021 | 20 | 145 | 15 | 261 |
| 2022 | 30 | 131 | 9 | 199 |
| 2023 | 27 | 139 | 9 | 310 |
| 2024 | 26 | 141 | 20 | 212 |
| 2025 | 27 | 141 | 17 | 219 |
| 2026 | 21 | 167 | 23 | — |
What is it indicated for?
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Precision has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician. FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis…
Read the full statement (101 words)
This device is indicated to acquire and display cross-sectional volumes of the whole body, to include the head. The Aquilion Precision has the capability to provide volume sets. These volume sets can be used to perform specialized studies, using indicated software/hardware, by a trained and qualified physician.
FIRST is an iterative reconstruction algorithm intended to reduce exposure dose and improve high contrast spatial resolution for abdomen, pelvis, chest, cardiac, extremities and head applications.
AICE is a noise reduction algorithm that improves image quality and reduces image noise by employing Deep Convolutional Neural Network methods for abdomen, pelvis, lung, and cardiac applications.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K220986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220986: Aquilion Precision (TSX-304A/4) V10.10 with AiCE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220986
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026